BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE-PIECE FOLDABLE INTRAOCUL

    MDR report key: 1002723 · Received February 26, 2008

    Report

    Report Number
    2023826-2008-00252
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 30, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING A ONE PIECE SILICONE LENS MODEL AA4204VF AND THE LENS BECAME STUCK INSIDE THE CARTRIDGE. THERE WAS NO PT CONTACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE-PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL: MSI-TM| CARTRIDGE MODEL: AQ CARTRIDGE-FP